RF ablation apparatus and method using controllable duty cycle with alternate phasing

ABSTRACT

An apparatus for delivering energy to a biological site includes a catheter having a plurality of electrodes, the electrodes positioned proximal the biological site. A power control system supplies power signals, each having a controllable phase angle, to each of the electrodes such that the phase between electrodes alternates. A backplate is also positioned proximal the biological site so that the biological site is interposed between the electrode device and the backplate. The backplate is maintained at one voltage level in relation to the power. The power control system controls the phase angle of the power so that the current flow between the electrodes and between the electrodes and the backplate results in the continuity and depth of lesions desired. In a preferred embodiment, the electrodes are arranged in a substantially linear array. The duty cycle of each electrode is controlled and during the off period of the duty cycle, the phase angles of adjacent electrodes are alternated to achieve a more uniform ablation volume.

BACKGROUND OF THE INVENTION

The invention relates generally to an electrophysiological ("EP")apparatus and method for providing energy to biological tissue, and moreparticularly, to the application of radio frequency ("RF") energy tocause a more uniform ablation volume in a biological site.

The heart beat in a healthy human is controlled by the sinoatrial node("S-A node") located in the wall of the right atrium. The S-A nodegenerates electrical signal potentials that are transmitted throughpathways of conductive heart tissue in the atrium to theatrioventricular node ("A-V node") which in turn transmits theelectrical signals throughout the ventricle by means of the His andPurkinje conductive tissues. Improper growth of, or damage to, theconductive tissue in the heart can interfere with the passage of regularelectrical signals from the S-A and A-V nodes. Electrical signalirregularities resulting from such interference can disturb the normalrhythm of the heart and cause an abnormal rhythmic condition referred toas "cardiac arrhythmia."

While there are different treatments for cardiac arrhythmia, includingthe application of anti-arrhythmia drugs, in many cases ablation of thedamaged tissue can restore the correct operation of the heart. Suchablation can be performed by percutaneous ablation, a procedure in whicha catheter is percutaneously introduced into the patient and directedthrough an artery to the atrium or ventricle of the heart to performsingle or multiple diagnostic, therapeutic, and/or surgical procedures.In such case, an ablation procedure is used to destroy the tissuecausing the arrhythmia in an attempt to remove the electrical signalirregularities or create a conductive tissue block to restore normalheart beat or at least an improved heart beat. Successful ablation ofthe conductive tissue at the arrhythmia initiation site usuallyterminates the arrhythmia or at least moderates the heart rhythm toacceptable levels. A widely accepted treatment for arrhythmia involvesthe application of RF energy to the conductive tissue.

In the case of atrial fibrillation ("AF"), a procedure published by Coxet al. and known as the "Maze procedure" involves continuous atrialincisions to prevent atrial reentry and to allow sinus impulses toactivate the entire myocardium. While this procedure has been found tobe successful, it involves an intensely invasive approach. It is moredesirable to accomplish the same result as the Maze procedure by use ofa less invasive approach, such as through the use of an appropriate EPcatheter system.

There are two general methods of applying RF energy to cardiac tissue,unipolar and bipolar. In the unipolar method a large surface areaelectrode; e.g., a backplate, is placed on the chest, back or otherexternal location of the patient to serve as a return. The backplatecompletes an electrical circuit with one or more electrodes that areintroduced into the heart, usually via a catheter, and placed inintimate contact with the aberrant conductive tissue. In the bipolarmethod, electrodes introduced into the heart have different potentialsand complete an electrical circuit between themselves. In the bipolarmethod, the flux traveling between the two electrodes of the catheterenters the tissue to cause ablation.

During ablation, the electrodes are placed in intimate contact with thetarget endocardial tissue. RF energy is applied to the electrodes toraise the temperature of the target tissue to a non-viable state. Ingeneral, the temperature boundary between viable and non-viable tissueis approximately 48° Centigrade. Tissue heated to a temperature above48° C. becomes non-viable and defines the ablation volume. The objectiveis to elevate the tissue temperature, which is generally at 37° C.,fairly uniformly to an ablation temperature above 48° C., while keepingboth the temperature at the tissue surface and the temperature of theelectrode below 100° C.

A basic configuration of an ablation catheter for applying RF energyincludes a distal tip which is fitted with an electrode device. Theelectrode device is the source of an electrical signal that causesheating of the contacting and neighboring tissue. In the unipolarmethod, the electrode device may include a single electrode used foremitting RF energy. This single electrode acts as one electrical pole.The other electrical pole is formed by the backplate in contact with apatient's external body part. A RF source is applied to the electrode.The RF source is typically in the 500 kHz region and produces asinusoidal voltage. When this is delivered between the distal tip of astandard electrode catheter and a backplate, it produces a localized RFheating effect and produces a well defined, deep acute lesion slightlylarger than the tip electrode.

In some procedures a lesion having a larger surface area than thatproduced by a single electrode in a unipolar arrangement may berequired. To this end numerous ablation catheters have been designed. Inone catheter designed to provide a larger surface ablation area, anelectrode device having four peripheral electrodes which extend from aretracted mode is used. See U.S. Pat. No. 5,500,011 to Desai. Whenextended, i.e., fanned out, the four peripheral electrodes and thecentral electrode form an electrode array that covers a larger surfacearea of the tissue than a single electrode. When used with aconventional RF power source, and in conjunction with a backplate, thefive electrodes produce five lesion spots distributed over the areaspanned by the electrode array. The lesions produced are discontinuousin relation to each other and there are areas between the electrodesthat remain unablated. This device must be manipulated so that whenexpanded, all electrodes are in contact with the endocardium. An "endon" approach is required such that the end of the catheter, on which allfive electrodes are mounted, is in intimate contact with the targettissue.

In another catheter an electrode device having a central electrode and anumber of peripheral electrodes which also fan out from a retracted modeis used. During ablation a backplate is not used; instead the centralelectrode functions as the reference while the peripheral electrodeshave multi-phase RF power applied to them. For example, see U.S. Pat.No. 5,383,917 to Desai et al. While this technique provides a morecontinuous lesion covering a larger surface area of the tissue, theablation volume is relatively shallow with a nonuniform depth of thelesion. This arrangement also requires the same manipulation of thecatheter such that an end-on contact is made by the expanded electrodes,as discussed above. Lesions having a non-uniform ablation volume areundesirable as the depth at one part of the lesion may not be sufficientto stop the irregular signal pathways. Arrhythmia may reoccur becausethe irregular signals may pass under such an ablation volume and theprocedure must then be repeated to once again attempt to obtain anablation volume having sufficient depth.

The mechanical configuration of both of the above-described techniquescomprises an expanding approach. When used for ablation, an electrodedevice is typically part of a catheter system. Accordingly, it isdesirable to minimize the diameter of the electrode device duringintroduction to and withdrawal from the patient to lessen trauma to thepatient. Therefore, electrode devices having peripheral expandableelectrodes must be configured so that the peripheral electrodes areexpandable to a large size yet are retractable to as small a size aspractical. Such requirements pose design and manufacturing difficultiesdue to the movement of mechanical parts required for proper operation.Further considerations are the undesirable complexity and increasedmanufacturing cost associated with an expandable a catheter.

Hence, those skilled in the art have recognized a need for astructurally stable minimally invasive ablation apparatus that iscapable of controlling the flow of current through a biological site sothat lesions with controllable surface and depth characteristics may beproduced and the ablation volume thereby controlled. Additionally, aneed has been recognized for establishing a more uniform depth ofablation throughout the lesion so that irregular signal paths do notcontinue to exist. The invention fulfills these needs and others.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the invention is directed to an apparatusand a method for controlling the application of energy to a biologicalsite during ablation to control the surface area, the continuity, andthe depth of lesion produced during ablation.

In a first aspect, the invention is directed to an apparatus fordelivering energy to a biological site comprising a catheter having aplurality of electrodes arranged at a distal end of the catheter andlocated at the biological site, a backplate positionable proximal thebiological site so that the biological site is interposed between theelectrodes and the backplate, and a power control system providing apower signal to each of the electrodes wherein the power signal to afirst electrode has a first phase angle and the power signal to a secondelectrode has a second phase angle and such that at least one powersignal has a voltage level that differs from the backplate so thatcurrent flows between said first and second electrodes and at least oneelectrode and the backplate, wherein the power control system alternatesthe phase angles between the first and second electrodes such that in afirst time period, the first and second electrodes have the first andsecond phase angles respectively and in a second time period, the firstand second electrodes have the second and first phase anglesrespectively.

In more detailed aspects, the power control system controls the dutycycle of each power signal with each duty cycle having an on period andan off period. The phase angles of each of the power signals are changedduring the off periods of the respective duty cycles. In yet moredetailed aspects, the power signals differ in phase by an amount greaterthan zero degrees but less than 180 degrees. In a further more detailedaspect, the power signals differ in phase angle by an amountapproximately equal to 132 degrees.

In another aspect, a temperature sensing device is located at theelectrodes for providing a temperature signal to the power controlsystem representative of the temperature at the electrodes, wherein thepower control system controls the duty cycle of a power signal inresponse to a temperature signal. In another aspect, a measurementdevice senses at least one characteristic of the power signal applied toat least one electrode and provides a power measurement signal, whereinthe power control system receives the power measurement signal anddetermines an impedance measurement based on the power signal andcontrols the duty cycle of a power signal in response to the powermeasurement signal.

In further aspects, the power control system provides separate powersignals to each of the plurality of electrodes with each power signalbeing individually controllable as to phase angle. The electrodes arearranged into a linear array at the distal end of the catheter. Further,a power interruption device connected to the power control systemwherein the power control system is adapted to control the powerinterruption device to interrupt power to a selected electrode.

These and other aspects and advantages of the present invention willbecome apparent from the following more detailed description, when takenin conjunction with the accompanying drawings which illustrate, by wayof example, the preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an ablation apparatus including a powercontrol system, electrode device and backplate;

FIGS. 2-1 and 2-2 form is a block diagram presenting more detail of apower control system in accordance with aspects of the invention,showing phase angle control, duty cycle control, and impedance andtemperature monitoring;

FIG. 3 is a diagram of a multi-channel ablation apparatus in accordancewith aspects of the invention wherein a single microprocessor controlsthe phase angle and duty cycle of each channel individually;

FIG. 4 depicts a first power waveform having a first phase angle andalternating instances of peak power and very low power;

FIG. 5 depicts a second power waveform having a second phase angledifferent from the first phase angle and alternating instances of peakpower and very low power;

FIG. 6 presents a time frame (TF) diagram showing a fifty-percent dutycycle;

FIG. 7A depicts the phase relationship and voltage potential between thefirst and second power waveforms having first and second phase anglesrespectively, as a function of time;

FIG. 7B depicts the phase relationship and voltage potential between thefirst and second power waveforms having second and first phase anglesrespectively, as a function of time;

FIGS. 8A, 8B, 8C, 8D, and 8E are schematic diagrams of an embodiment ofa power control system in accordance with aspects of the invention withFIG. 8A showing how FIGS. 8B, 8C, 8D and 8E are related;

FIG. 9A is a three dimensional representation of an ablation apparatushaving a linear array of band electrodes in contact with a biologicalsite with a backplate at the opposite side of the biological site, inwhich the phase angle difference between adjacent electrodes of thelinear array is zero degrees;

FIGS. 9B through 9D depict, along the x, y, and z axes shown, the depthof the lesions formed by the ablation apparatus of FIG. 9A showing thatthe apparatus acts as a unipolar device with multiple electrodes and theresulting lesions are discontinuous;

FIG. 10A is a three dimensional representation of an ablation apparatushaving a linear array of band electrodes in contact with a biologicalsite with a backplate at the opposite side of the biological site, inwhich the phase angle difference between adjacent electrodes is 180degrees;

FIGS. 10B through 10D depict, along the x, y, and z axes shown, thecontinuity and depth of a lesion formed by the ablation apparatus ofFIG. 10A showing that the apparatus acts as a bipolar device with nosignificant amount of current flowing to the backplate;

FIG. 11A is a three dimensional representation of an ablation apparatushaving a linear array of band electrodes in contact with a biologicalsite with a backplate at the opposite side of the biological site, inwhich the phase difference between adjacent electrodes is approximately90 degrees; and

FIGS. 11B through 11D depict, along the x, y, and z axes shown, thecontinuity and depth of a lesion formed by the ablation apparatus ofFIG. 11A showing the greater depth of lesion resulting from the phaseangle difference.

FIG. 12 presents a block diagram of the current flow among electrodesand the backplate through the biological site for adjacent electrodeshaving different phase angles;

FIG. 13 presents the same block diagram as FIG. 12 with the phase anglesbetween adjacent electrodes reversed; and

FIGS. 14A through 14D present, along the x, y, and z axes shown, theincreased continuity, depth, and uniformity of a lesion formed by thealternating phase apparatus and method shown in previous figures.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, in which like reference numerals are usedto designate like or corresponding elements among the several figures,in FIG. 1 there is shown an ablation apparatus 10 in accordance withaspects of the present invention. The apparatus 10 includes a powercontrol system 12 that provides power or drive 14 to an electrode device16. The power control system 12 comprises a power generator 18 that mayhave any number of output channels through which it provides the power14. The operation of the power generator 18 is controlled by acontroller 20 which outputs control signals 21 to the power generator18. The controller 20 monitors the power 14 provided by the powergenerator 18. In addition, the controller 20 also receives temperaturesignals 22 from the electrode device 16. Based on the power 14 andtemperature signals 22 the controller 20 adjusts the operation of thepower generator 18. A backplate 24 is located proximal to the biologicalsite 26 opposite the site from the electrode device 16, and is connectedby a backplate wire 28 to the power generator 18.

The backplate 24 is set at the reference level to the power provided tothe electrodes, as discussed in detail below.

The electrode device 16 is typically part of a steerable EP catheter 30capable of being percutaneously introduced into a biological site 26, e.g., the atrium or ventricle of the heart. The electrode device 16 isshown in schematic form with the components drawn to more clearlyillustrate the relationship between the components and the relationshipbetween the components and the power control system 12. In thisembodiment, the catheter 30 comprises a distal segment 34 and a handle31 located outside the patient. A preferred embodiment of the electrodedevice 16 includes twelve band electrodes 32 arranged in a substantiallylinear array along the distal segment 34 of the catheter 30. Theelectrode device 16 may include a tip electrode 36. (For clarity ofillustration, only four band electrodes 32 are shown in the figuresalthough as stated, a preferred embodiment may include many more.) Theband electrodes 32 are arranged so that there is space 38 betweenadjacent electrodes. In one configuration of the electrode device 16,the width of the band electrodes 32 is 3 mm and the space 38 between theelectrodes is 4 mm. The total length of the electrode device 16, assuch, is approximately 8 cm.

The arrangement of the band electrodes 32 is not limited to a lineararray and may take the form of other patterns. A substantially lineararray is preferred for certain therapeutic procedures, such as treatmentof atrial fibrillation, in which linear lesions of typically 4 to 8 cmin length are desired. A linear array is more easily carried by thecatheter 30 and also lessens the size of the catheter.

The band electrodes 32 are formed of a material having a significantlyhigher thermal conductivity than that of the biological tissue 26.Possible materials include silver, copper, gold, chromium, aluminum,molybdenum, tungsten, nickel, platinum, and platinum/10% iridium.Because of the difference in thermal conductivity between the electrodes32 and the tissue 26, the electrodes 32 cool off more rapidly in theflowing fluids at the biological site. The power supplied to theelectrodes 32 may be adjusted during ablation to allow for the coolingof the electrodes while at the same time allowing for the temperature ofthe tissue to build up so that ablation results. The electrodes 32 aresized so that the surface area available for contact with fluid in theheart, e.g., blood, is sufficient to allow for efficient heatdissipation from the electrodes to the surrounding blood. In a preferredembodiment, the electrodes 32 are 7 French (2.3 mm in diameter) with alength of 3 mm.

The thickness of the band electrodes 32 also affects the ability of theelectrode to draw thermal energy away from the tissue it contacts. Inthe present embodiment, the electrodes 32 are kept substantially thin sothat the electrodes effectively draw energy away from the tissue withouthaving to unduly increase the outer diameter of the electrode. In apreferred embodiment of the invention, the thickness of the bandelectrodes is 0.05 to 0.13 mm (0.002 to 0.005 inches).

Associated with the electrode device 16 are temperature sensors 40 formonitoring the temperature of the electrode device 16 at various pointsalong its length. In one embodiment, each band electrode 32 has atemperature sensor 40 mounted to it. Each temperature sensor 40 providesa temperature signal 22 to the controller 20 which is indicative of thetemperature of the respective band electrode 32 at that sensor. Inanother embodiment of the electrode device 16 a temperature sensor 40 ismounted on every other band electrode 32. Thus for a catheter havingtwelve electrodes, there are temperature sensors on six electrodes. Inyet another embodiment of the electrode device 16 every other electrodehas two temperature sensors 40. In FIG. 1, which shows an embodimenthaving one temperature sensor for each electrode, there is shown asingle power lead 15 for each electrode 32 to provide power to eachelectrode for ablation purposes and two temperature leads 23 for eachtemperature sensor 40 to establish the thermocouple effect.

In another approach, the drive wire may comprise one of the thermocouplewires or may comprise a common wire for a plurality of thermocouplesmounted on the same electrode. The inventor hereby incorporates byreference his pending application Ser. No. 09/072,800 entitled "CatheterHaving Common Lead for Electrode and Sensor" filed may 5, 1998, and hispending application Ser. No. 09/072,853 entitled "Electrode HavingNon-Joined Thermocouple for Providing Multiple Temperature-SensitiveJunctions" filed may 5, 1998.

Turning now to FIGS. 2-1 and 2-2 a block diagram of an ablationapparatus 10 and method in accordance with aspects of the invention ispresented. In FIGS. 2-1 and 2-2 a single channel of the power controlsystem 12 is depicted. This channel controls the application of power toa single electrode 32. As will be discussed in relation to otherfigures, a channel may control a plurality or group of electrodes. InFIG. 2-1, a microprocessor 42, which is part of the controller 20 (FIG.1), provides a duty cycle control signal 44 to a duty cycle generator("DCG") 45. In this case, the duty cycle generator 45 receives thecontrol signal 44 by an 8-bit latch 46. The latch 46 provides an 8-bitsignal 47 to a duty cycle comparator 48. The comparator 48 compares the8-bit signal 47 to a count from an 8-bit duty cycle counter 50 and 30 ifthe count is the same, provides a duty cycle off signal 49 to the dutycycle gate 52. The gate 52 is connected to a frequency source 54, suchas an oscillator that produces 500 kHz. When the gate 52 receives theduty cycle off signal 49 from the comparator 48, it stops its output ofthe frequency source signal through the gate and no output exists.

At a frequency of 500 kHz, an 8-bit control has a period or time frameof 0.5 msec. At a fifty-percent duty cycle, the electrode is in the offperiod only 0.25 msec. To allow for greater cooling of the electrode,the period or time frame 78 (FIG. 6) is lengthened by use of a prescalar56 interposed between the frequency source 54 and the counter 50. In oneembodiment, the prescalar 56 lengthens the period to 4 msec thusallowing for a 2 msec off period during a fifty-percent duty cycle. Thisresults in a sufficient cooling time for the very thin band electrodesdiscussed above. Other lengths of the period may be used depending onthe circumstances. It has been found that a ten percent duty cycle isparticularly effective in ablating heart tissue. The combination of theapplication of high peak power, a ten percent duty cycle, the use ofhigh thermal conductivity material in the band electrodes, and fluidsflowing past the band electrodes which have a cooling effect on theelectrodes result in a much more effective application of power to thetissue. Ablation occurs much more rapidly.

A terminal count detector 58 detects the last count of the period andsends a terminal count signal 59 to the gate 52 which resets the gatefor continued output of the frequency source signal. This then beginsthe on period of the duty cycle and the counter 50 begins its countagain. In one preferred embodiment, the duty cycle is set at fiftypercent and the 8-bit latch is accordingly set to 128. In anotherembodiment, the duty cycle is set at ten percent.

A programmable logic array ("PLA") 60 receives phase control signals 61from the microprocessor 42 and controls the phase of the frequencysource 54 accordingly. In one embodiment, the PLA 60 receives theterminal count signal 59 from the terminal count detector 58 and onlypermits phase changes after receiving that terminal count signal.

The output signal from the gate 52 during the on period of the dutycycle is provided to a binary power amplifier ("BPA") 62 that increasesthe signal to a higher level, in this case, 24 volts. The amplifiedsignals are then filtered with a band pass filter ("BPF") 64 to convertthe somewhat square wave to a sine wave. The band pass filter 64 in oneembodiment is centered at 500 kHz. The filtered signal is then providedto an isolated output transformer ("IOT") 66 that amplifies the signalto a much higher level, for example 350 volts peak-to-peak. This signalis then sent to a relay interconnect ("RI") 67 before it is provided asa power output signal OUTn 14 to an electrode 32 at the biological siteto cause ablation.

The power output signal 14 from the isolated output transformer 66 ismonitored in one embodiment to determine the impedance at the electrode32. In the embodiment shown in FIGS. 2-1 and 2-2 a voltage and currentmonitor ("VCM") 68 is used. The monitor signal 69 is converted todigital form by an A-to-D converter ("ADC") 70 and provided to themicroprocessor 42. As previously mentioned, some or all of theelectrodes 32 may include a temperature sensor 40 (FIG. 1) that providestemperature signals 22 (FIG. 2-2) which are used to determine thetemperature at the electrode 32. In one embodiment of the invention, thepower 14, in conjunction with the temperature signals 22, are used todetermine the temperature at the electrode 32. Both the temperaturesignals 22 and the power 14 pass through a temperature filter ("FL") 73before being sent to the microprocessor 42. In the alternative, thetemperature filter 73 is contained in a printed circuit board separatefrom the controller 20 and contains its own processor. In either case,the filter 73 filters out any RF noise present in the power 14 so thatthe signal may be used for temperature monitoring purposes. In anotherembodiment, the microprocessor monitors the power 14 and temperaturesignals 22 only during the off periods of the power 14 duty cycle.Accordingly, negligible RF noise is present in the power line andfiltration is not necessary. In either embodiment, the microprocessor 42may alter the duty cycle of the power 14 in response to either or bothof the impedance or temperature signals.

In a manual arrangement, the temperature sensed and/or the determinedimpedance may be displayed to an operator. The operator in response maythen manually control the duty cycle or other power parameters such asby rotating a knob mounted on a front panel of an instrument. In thecase of a multiple channel instrument and catheter, as discussed below,multiple knobs may be provided in this manual arrangement for controlover each channel.

Referring now to FIG. 3, a multiple channel ablation apparatus is shown.Although only three complete channels are shown, the apparatus comprisesmany more as indicated by the successive dots. Those channels are notshown in FIG. 3 to preserve clarity of illustration. By providingdifferent voltage levels between two electrodes 32 in an array, currentflows between those electrodes in a bipolar electrode approach. Bysetting the backplate 24 (FIG. 1) at a voltage level different from atleast one of those electrodes 32, current flows between that electrodeand the backplate. By controlling the voltage levels among the three(two electrodes and backplate), the current flow through the biologicalsite 26 can be more precisely controlled. One technique for settingdifferent voltage levels between the electrodes 32 is to maintain aphase difference between them in an AC approach. By setting thebackplate 24 at the reference level, current flows between theelectrodes 32 and the backplate.

The single microprocessor 42, which again is part of the controller 20(FIG. 1), controls the duty cycle and the phase of each channelindividually in this embodiment. Each channel shown comprises the sameelements and each channel produces its own power output signal 14 (OUT1,OUT2, through OUTn where "n" is the total number of channels) onrespective electrode leads (LEAD 1, LEAD 2, through LEAD n where "n" isthe total number of leads) to the electrodes 32. This multi-channelapproach permits more individual control over each electrode. Forexample, the duty cycle of the power applied to each electrode can beindividually controlled. One electrode may have a ten percent duty cyclewhile another has a thirty percent duty cycle.

Referring now to the first and second output signals OUT1 and OUT2 ofFIG. 3, the signals, as shown in FIGS. 4, 5, and 6, have alternatinginstances of peak power i.e., "on" periods 74, and very low power 76,i.e., "off" periods. Typically, the output power 14 is a 500 kHz sinewave. In FIGS. 4 and 5, the number of cycles of the sine wave containedwithin one on period 74 has been substantially reduced in the drawing toemphasize the phase difference between the first and second outputsignals OUT1, OUT2. Preferably, the voltage of each power signal 14during an off period 76 is substantially zero and during an on period 74is approximately 350 volts peak-to-peak.

The power OUT1 and OUT2 also have a variable duty cycle for controllingthe length of the on period 74 and the off-period 76 within a time frame78 (see FIG. 6). The duty cycle is the ratio of the length of the onperiod 74 to the length of the entire time frame 78. The effective poweris the peak power times the duty cycle. Thus, a signal having a peakpower of 100 watts and a 50% duty cycle has an effective power of 50watts.

As shown in FIGS. 4, 5, and 6, the two power signals OUT1, OUT2 arephased differently from each other. As discussed above, the phase angleof each power signal is set and controlled by the processor 42 and PLA60. Each power signal OUT1 and OUT2 has a respective phase angle andthose phase angles differ between the two of them. The phase angledifference between the power OUT1 and OUT2 produces a voltage potentialbetween the band electrodes 32 (FIG. 1) that receive the power. Thisvoltage potential, in turn, induces current flow between the bandelectrodes 32. The phase angle relationship of the power and the voltagepotential produced as a function of time is shown in FIGS. 7A and 7B.The potential between electrodes V_(e-e) is defined by: ##EQU1##

FIG. 7A shows first and second power OUT1 and OUT2 provided to first andsecond electrodes respectively having a phase angle difference ΔΦ withOUT1 leading OUT2 by 132 degrees. FIG. 7B shows the same power OUT1 andOUT2 but with the phase angles reversed where OUT2 is now leading OUT1by 132 degrees.

With reference now to FIG. 8A-8E schematic diagrams of an embodiment ofthe ablation apparatus 10 of FIGS. 2-1 and 2-2 are presented in FIGS. 8Bthrough 8E while FIG. 8A shows how FIGS. 8B through 8E should beoriented in relation to each other. The frequency source 54 provides asignal 80, typically at 500 kHz with a phase angle controlled by themicroprocessor 42 through the PLA 60, to the duty cycle generator 45.The duty cycle generator 45 modulates the frequency source signal 80 toproduce the selected duty cycle in accordance with the duty cyclecontrol signal 44 as previously described. The duty cycle generator 45outputs two signals 82 and 84 to the binary power amplifier 62. A dualMOSFET driver U2 receives the signals, converts their 5 V level to a 12V level, and sends each to a transformer T2 which transforms the signalsinto 24 V peak-to-peak power.

The 24 V power is then sent to a multi-state driver 86 which includes aconfiguration of FETs Q2, Q3, Q4, and Q5. During a conducting state ofthe driver 86, which is typically the on period 74 of the power, theseFETs Q2 through Q5 conduct and forward the power to a bandpass filter 64comprising a series LC network. During a high-impedance state of thedriver 86, which is typically during the off period 76 of the power, theFETs Q2 through Q5 are nonconducting and no power is sent to thebandpass filter 64. Instead the FETs Q2 through Q5 present a highimpedance load to any signals received through the electrode 32.Typically the load impedance on the FETs Q2 through Q5 presented by thecircuit following the FETs , the electrode, and the tissue isapproximately 150 Ω but transformed through the output transformer T3,it presents a load impedance to the FETs Q2-Q5 of approximately 0.5 to 1Ω. In the off state, the FETs present an impedance of approximately 250Ω which is large in comparison to the transformed load impedance ofapproximately 0.5 to 1 Ω. Therefore, very little power flows when theFETs are in the off state.

The bandpass filter 64 operates to shape the output signal provided bythe binary amplifier 62 from a square wave to a sinusoidal wave. Thefiltered signal 85 then passes to the isolated output section 66 whereit is step-up transformed to 350 volt peak-to-peak sinusoidal power atT3. The power is then split into two identical power signals OUT1A,OUT1B and provided to two or more respective band electrodes 32 on theoutput lines LEAD1A, LEAD1B.

The isolated output section 66 also includes relays 88 that may beindividually opened to remove the power signals OUT1A, OUT1B from theelectrode leads LEAD 1A, LEAD 1B when an alert condition is detected,such as high temperature or high impedance at the respective electrode32. As previously mentioned these conditions are determined by themicroprocessor 42 which receives signals indicative of the temperatureand impedance at each of the band electrodes 32.

The power from the isolated output section 66 is monitored andrepresentative signals are supplied to an RF voltage and current monitor68 where in this case, the voltage and current of each output signal aremeasured to determine the impedance of the particular channel. Themeasured signals are sent to an A-to-D converter 70 (FIG. 2) beforebeing sent to the microprocessor 42 for impedance monitoring. If theimpedance is above a threshold level indicative of blood clotting orboiling, the microprocessor 42 sends a signal to the duty cyclegenerator 45 to reduce or discontinue the duty cycle of the power OUT1A,OUT1B and thus lower the effective power delivered to the bandelectrodes 32.

Similarly, the temperature at the electrodes 32 is determined bymonitoring the power 14 and temperature signals 22 and measuring thevoltage difference between the signals. As previously mentioned, in oneembodiment of the invention, these signals pass through a filter 73(FIG. 2-2) before being sent to the microprocessor 42. The voltage valueis converted to a temperature and if the temperature is above athreshold level the duty cycle of the power 14 is reduced.

In the case where a single lead is used to provide a signal which isused to determine the temperature as well as provide power to theelectrode 32, the signal from the lead is received on temperature leads87, 89 connected at the output side of the relays 88.

As shown in FIG. 3, the duty cycle of each electrode 32 may beindividually controlled by the microprocessor 42. As previouslymentioned, based on the temperature at an electrode 32 and the currentand voltage of the output signal provided to an electrode, the dutycycle of the output signal may be adjusted. For example, one electrode32 may have a temperature requiring a duty cycle of ten percent, whileanother electrode may have a temperature which allows for a fiftypercent duty cycle. In an embodiment in which every other electrode 32has a temperature sensor 40, the electrodes are grouped in pairs witheach electrode in the pair having the same duty cycle.

In operation, as depicted in FIGS. 9a through 11d, the electrode device16 and the backplate 24 are positioned proximal the biological site 26undergoing ablation such that the biological site is interposed betweenthe electrode device and the backplate. The band electrodes 32 (only oneof which is indicated by a numeral 32 for clarity of illustration) ofthe electrode device 16 each receives power OUT1, OUT2, OUT3, OUT4having a phase angle on LEAD 1 through LEAD 4. In one embodiment, everyother electrode 32 receives the same phase angle. Therefore, the phaseangle of electrode A equals the phase angle of electrode C and the phaseangle of electrode B equals the phase angle of electrode D. Theadvantages of this arrangement are described below. In a preferredembodiment, the electrodes 32 are formed into a linear array as shown.In addition, a thermocouple temperature sensor 40 is located at each ofthe electrodes A, B, C, and D and uses the electrode power lead LEADS 1through 4 as one of the sensor leads. The sensors 40 provide temperaturesensor signals 22 for receipt by the power control system 12.

In another embodiment, alternate electrodes 32 may be grouped togetherand each may receive the same power having the same phase angle and dutycycle. Another group or groups of electrodes 32 may be interspaced withthe first group such that the electrodes of one group alternate with theelectrodes of the other group or groups. Each electrode 32 in aparticular group of electrodes has the same phase angle and duty cycle.For example, electrodes A and C may be connected to the same power whileinterspaced electrodes B and D may be connected to a different poweroutput signal.

The use of individual power signals also provides the ability to disableany combination of electrodes 32 and thereby effectively change thelength of the electrode device 16. For example, in one configuration ofthe present invention an electrode device 16 with twelve electrodes 32receives twelve power signals from a twelve channel power control system12. The electrodes 32 are 3 mm in length and are 4 mm apart.Accordingly, by disabling various electrodes, a virtual electrode of anylength from 3 mm to 8 cm may be produced by the electrode device 16. Ineither arrangement the backplate 24 is maintained at the referencevoltage level in regard to the voltage level of the power OUT1 throughOUTn.

As previously described, by varying the phase angles between the powerOUT1, OUT2 supplied to each electrode 32, a phase angle difference isestablished between adjacent band electrodes. This phase angledifference may be adjusted to control the voltage potential betweenadjacent band electrodes 32 and thus to control the flow of currentthrough the biological site 26. The flow of current I_(e-e) betweenadjacent band electrodes 32 is defined by: ##EQU2##

In addition to the current flow between the band electrodes 32 there iscurrent flow between the band electrodes and the backplate 24. When thebackplate 24 is set at the reference level, this current flow I_(e-b) isdefined by: ##EQU3##

Assuming Z_(e-b) and Z_(e-e) are equal, the ratio of the current flowingbetween the band electrodes 32 I_(e-e) to the current flowing betweenthe band electrodes 32 and the backplate 24 I_(e-b) is defined by:##EQU4##

where: ΔΦ=phase angle difference between electrodes FIGS. 9A through 11Dillustrate various current flow patterns within a biological site. Thedepths and widths of the lesions depicted in FIGS. 9 through 11 are notnecessarily to scale or in scalar proportion to each other but areprovided for clarity in discerning the differences between the variouspower application techniques. When the phase difference between adjacentelectrodes 32 is zero degrees, no current flows between the electrodesin accordance with Eq. 2 above, and the apparatus operates in a unipolarfashion with the current flowing to the backplate 24 as shown in FIGS.9A through 9D. Substantially all current flows from the band electrodes32 to the backplate 24 forming a series of relatively deep, acutelesions 90 along the length of the electrode device 16. As seen in thetop view of FIG. 9B and the side view of FIG. 9D, the lesions arediscrete. The lesions 90 are discontinuous in regard to each other.

When the phase difference between adjacent electrodes 32 is 180 degreesthe apparatus operates in both a unipolar and bipolar fashion and thecurrent flow pattern is as shown in FIG. 10A. With this phasedifference, approximately twice as much current flows between adjacentband electrodes 32 than flows from the band electrodes to the backplate24. The resulting lesion 92 is shallow but is continuous along thelength of the electrode device 16. The continuity and shallow depth ofthe lesion 92 are illustrated in FIGS. 10B through 10D. Nevertheless,the lesion depth is still greater than that created by prior bipolarablation methods alone.

When the phase difference between adjacent electrodes 32 is set withinthe range of a value greater than zero to less than 180 degrees, thecurrent flow varies from a deep, discontinuous unipolar pattern to amore continuous, shallow bipolar pattern. For example, when the phasedifference between adjacent electrodes 32 is around 90 degrees, thecurrent flows as shown in FIG. 11A. With this phase difference, currentflows between adjacent band electrodes 32 as well as between the bandelectrodes and the backplate 24. Accordingly, a lesion which is bothdeep and continuous along the length of the electrode device 16 isproduced. The continuity and depth of the lesion 94 is illustrated inFIGS. 11B through 11D. In one embodiment of FIG. 11A, adjacentelectrodes alternated in phase but were provided with power in groups.Electrodes A and C were provided with power at a first phase angle andelectrodes B and D were provided with power at a second phase angle,different from the first.

Thus, in accordance with the present invention the phase angle of thepower may be adjusted in order to produce a lesion having differentdepth and continuity characteristics. In selecting the phase angledifference necessary to produce a continuous lesion having the greatestpossible depth, other elements of the electrode device 16 areconsidered. For example, the width of the band electrodes 32 and thespacing between the electrodes are factors in selecting an optimum phaseangle. In a preferred embodiment of the present invention, as pointedout above, the width of the band electrodes is 3 mm, the spacing betweenthe electrodes is 4 mm and the electrodes receive power which establisha phase difference of 132 degrees between adjacent electrodes. With thisconfiguration a long continuous lesion having a length of betweenapproximately 3 mm and 8 cm and a depth of 5 mm or greater was produceddepending on the number of electrodes energized, the duty cycleemployed, and the duration of power application.

In another embodiment of the invention, energy is applied to thebiological tissue 26 during the on period of the duty cycle in analternating unipolar-bipolar manner. During the unipolar mode segment avoltage potential is established between the electrodes 32 and thebackplate 24. Thus current flows through the tissue 26 between theelectrodes 32 and the backplate 24.

During the bipolar mode segment a voltage potential is establishedbetween at least two of the electrodes 32 rather than between theelectrodes and the backplate 24. Thus current flows through the tissue26 between the electrodes 32. While operating in this mode the voltagedifference between the electrodes 32 may be established by providingpower with different phase angles to the electrodes as previouslymentioned. Alternatively, some of the electrodes 32 may be connected toa reference potential while others are maintained at a different voltagelevel.

By adjusting the duration of the unipolar and bipolar mode segmentswithin the on period of the duty cycle, the continuity and depth of thelesion produced may be controlled. For example, operating in theunipolar mode for one-fourth of the on period and in the bipolar modefor three-fourths of the on period produces a lesion having a continuityand depth similar to the lesion 94 illustrated in FIGS. 11B through 11D.

Referring to FIGS. 8B through and 8E, the following devices are shown:

    ______________________________________                                        Device       Part No.    Manufacturer                                         ______________________________________                                        U1           GAL6002B    Lattice                                              U2           SN75372     numerous                                             Q1           1RFZ34N     numerous                                             Q2, Q3, Q4, Q5                                                                             1RFZ44N     numerous                                             Q7, Q8, Q9   MPF6601     numerous                                             R3, R5       1Ω    numerous                                             T1, T4       CMI-4810    Corona Magnetics, Inc.                               T2           GFS97-0131-1                                                                              GFS Manufacturing                                    T5           CMI-4809    Corona Magnetics, Inc.                               ______________________________________                                    

The transformer denoted by "T3" is a 1:12 turns ratio, single turnprimary, step up transformer wound on a TDK core PC50EER23Z.

FIG. 12 presents a block diagram of the current flow among electrodes 32and the backplate 24 through the biological site 26 for adjacentelectrodes having different phase angles where the phase angles of the Aand C electrodes lead the phase angles of the B and D electrodes. It hasbeen noted that with the approach shown in FIG. 12, the vector sum ofthe currents flowing through the site 26 is such that more current flowsat one or more electrodes than at others. This is shown figurativelywith shorter arrows leading to the backplate from the B and Delectrodes. Although the ablation volume is greater than in the priortechniques, the ablation volume appears irregular or nonuniform as shownin FIG. 11D. It is desirable to have a more uniform ablation volume,especially as to depth, so that irregular electrical signals do not passunder the ablation volume at a point having less depth and require arepeat of the ablation procedure.

FIG. 13 presents the same block diagram as FIG. 12 with the phase anglesbetween adjacent electrodes reversed. In FIG. 13, the phase angles ofthe power at the B and D electrodes 32 now lead the phase angles of thepower at the A and C electrodes 32. The change in current flow due tothis opposite phasing is represented figuratively with shorter arrowsnow at the A and C electrodes thus balancing the current flow pattern ofFIG. 12. It has been found that by alternating the phase angles such asshown in FIGS. 12 and 13, a much more uniform current flow and much moreuniform ablation volume result. A cumulative effect of the current flowcauses the tissue between all the band electrodes 32 and the backplate24 to become ablated, depth-wise through the biological site 26, at asubstantially even rate and thus a lesion having substantially uniformdepth is produced. This is shown in FIGS. 14A through 14D where anablation volume 96 is shown, which has much greater uniformity in shape.In particular, the ablation lesion 96 has a uniform depth and gives riseto a high level of confidence that the ablation volume created with theablation apparatus in accordance with the invention will successfullydestroy the tissue causing the arrhythmia.

In one embodiment, the phase between the electrodes was alternated asshown in FIGS. 12 and 13 only during the off period of the duty cycle.That is, and with reference to FIG. 6, during the entire on period 74 ofthe duty cycle of one time frame 78, the phase angles of the power atthe A and C electrodes 32 led the phase angles of the power at the B andD electrodes 32 by 132 degrees. During the following off period 76 ofthe same time frame 78, the phase angles of the power to be supplied waschanged to be opposite those phase angles used during the on period 74,in preparation for the next on period. Then at the next on period 74,the phase angles of the power provided to electrodes B and D led thephase angles of the power provided to the A and C electrodes by 132degrees during that entire on period. During the immediately subsequentoff period, the phase angles were again changed so that electrodes A andC would lead electrodes B and D.

The inventor hereby incorporates by reference his pending applicationSer. No. 09/073,112 filed may 5, 1998, entitled "RF Ablation ApparatusHaving High Output Impedance Drivers," and his pending application Ser.No. 09/073,392 filed May 5, 1998. entitled "RF Ablation Apparatus andMethod Using Unipolar and Bipolar Techniques," both of which areassigned to the assignee of the present invention.

While several particular forms of the invention have been illustratedand described, it will be apparent that various modifications can bemade without departing from the spirit and scope of the invention. Forexample, the controller 20 is shown in FIG. 1 as forming a part of thepower control system 12. However, it may take other forms such as anexternal processor in a separate computer for example. Likewise, dutycycle control and phase control may be performed by circuits other thanthose shown here. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

What is claimed is:
 1. An apparatus for delivering energy to hearttissue, said apparatus comprising:a catheter having a plurality ofelectrodes arranged at a distal end of the catheter, the distal endpositionable so that the electrodes are located at the heart tissue; abackplate positionable proximal the heart tissue so that the hearttissue is interposed between the electrodes and the backplate; and apower control system providing power to each of the electrodes whereinthe power to a first electrode has a first phase angle and the power toa second electrode has a second phase angle and such that the powerprovided to at least one electrode has a voltage level that differs fromthe backplate so that current flows between said first and secondelectrodes and between at least one electrode and the backplate; whereinthe power control system alternates the phase angles between the firstand second electrodes such that in a first time period, the first andsecond electrodes have the first and second phase angles respectivelyand in a second time period, the first and second electrodes have thesecond and first phase angles respectively.
 2. The apparatus of claim 1wherein the power control system controls the duty cycle of the powerwith the duty cycle having an on period and an off period.
 3. Theapparatus of claim 2 wherein the phase angles of the power provided tothe electrodes are changed during the off periods of the respective dutycycles.
 4. The apparatus of claim 2 further comprising:a temperaturesensing device located at an electrode that provides a temperaturesignal to the power control system representative of the temperature atthe electrode; wherein the power control system controls the duty cycleof the power in response to the temperature signal.
 5. The apparatus ofclaim 2 further comprising:a measurement device that senses at least onecharacteristic of the power applied to at least one electrode andprovides a power measurement signal; wherein the power control systemreceives the power measurement signal and determines an impedancemeasurement based on the power measurement signal and controls the dutycycle of the power in response to the power measurement signal.
 6. Theapparatus of claim 5 further comprising:a temperature sensing devicelocated at an electrode for providing a temperature signal to the powercontrol system representative of the temperature at the electrode;wherein the power control system controls the duty cycle of the power inresponse to the temperature signal and in response to the powermeasurement signal.
 7. The apparatus of claim 1 wherein the powerprovided to the electrodes differs in phase by an amount greater thanzero degrees but less than 180 degrees.
 8. The apparatus of claim 7wherein the power provided to the electrodes differs in phase byapproximately 132 degrees.
 9. The apparatus of claim 1 wherein the powercontrol system provides separate power to each of the plurality ofelectrodes with the power provided to each electrode being individuallycontrollable as to phase angle.
 10. The apparatus of claim 9 wherein theplurality of electrodes are arranged into a linear array at the distalend of the catheter.
 11. The apparatus of claim 1 further comprising:apower interruption device connected between the power control system andthe electrodes; wherein the power control system is adapted to controlthe power interruption device to interrupt power to a selectedelectrode.
 12. The apparatus of claim 1 further comprising:a temperaturesensing device located at an electrode that provides a temperaturesignal to the power control system representative of the temperature atthe electrode; wherein the power control system controls the duty cycleof the power in response to the temperature signal.
 13. The apparatus ofclaim 1 further comprising:a measurement device that senses at least onecharacteristic of the power applied to at least one electrode andprovides a power measurement signal; wherein the power control systemreceives the power measurement signal and determines an impedancemeasurement based on the power measurement signal and controls the dutycycle of the power in response to the power measurement signal.
 14. Theapparatus of claim 13 further comprising:a temperature sensing devicelocated at an electrode that provides a temperature signal to the powercontrol system representative of the temperature at the electrode;wherein the power control system controls the duty cycle of the power inresponse to the temperature signal and in response to the powermeasurement signal.
 15. An apparatus for delivering energy to abiological site, said apparatus comprising:a catheter having a pluralityof electrodes arranged at a distal end of the catheter, the distal endpositionable so that the electrodes are located at the biological site;a backplate positionable proximal the biological site so that thebiological site is interposed between the electrodes and the backplate;and a power control system providing power to each of the electrodeswherein the power to a first electrode has a first phase angle and thepower to a second electrode has a second phase angle and such that thepower to at least one electrode has a voltage level that differs fromthe backplate so that current flows between said first and secondelectrodes and between at least one electrode and the backplate; whereinthe power control system alternates the phase angles between the firstand second electrodes such that in a first time period, the first andsecond electrodes have the first and second phase angles respectivelyand in a second time period, the first and second electrodes have thesecond and first phase angles respectively; and wherein the powercontrol system controls the duty cycle of the power with the duty cyclehaving an on period and an off period.
 16. The apparatus of claim 15wherein the phase angles of the power provided to the electrodes arechanged during the off periods of the respective duty cycles.
 17. Theapparatus of claim 15 wherein the power provided to the electrodesdiffers in phase by an amount greater than zero degrees but less than180 degrees.
 18. The apparatus of claim 17 further comprising:atemperature sensing device located at an electrode that provides atemperature signal to the power control system representative of thetemperature at the electrodes; wherein the power control system controlsthe duty cycle of the power in response to the temperature signal. 19.The apparatus of claim 17 further comprising:a measurement device thatsenses at least one characteristic of the power applied to at least oneelectrode and provides a power measurement signal; wherein the powercontrol system receives the power measurement signal and determines animpedance measurement based on the power measurement signal and controlsthe duty cycle of the power in response to the power measurement signal.20. The apparatus of claim 19 further comprising:a temperature sensingdevice located at an electrodes that provides a temperature signal tothe power control system representative of the temperature at theelectrode; wherein the power control system controls the duty cycle ofthe power in response to the temperature signal and in response to thepower measurement signal.
 21. The apparatus of claim 20 wherein theelectrodes are arranged into a linear array at the distal end of thecatheter.
 22. The apparatus of claim 15 wherein the power provided tothe electrodes differs in phase by an amount approximately equal to 132degrees.
 23. The apparatus of claim 15 wherein the power control systemprovides separate power to each of the plurality of electrodes with thepower provided to each electrode being individually controllable as tophase angle.
 24. The apparatus of claim 15 further comprising:a powerinterruption device connected to the power control system; wherein thepower control system is adapted to control the power interruption deviceto interrupt power to a selected electrode.
 25. A method for deliveringenergy to a biological site, the method comprising the steps of:locatingat the biological site a catheter having a plurality of electrodesarranged at a distal end; positioning a backplate proximal thebiological site so that the biological site is interposed between theelectrodes and the backplate; providing power to each of the electrodeswith the power to a first electrode having a first phase angle and thepower to a second electrode having a second phase angle such that atleast one electrode has a voltage level that differs from the backplateso that current flows between said first and second electrodes andbetween at least one electrode and the backplate; alternating the phaseangles of the power between the first and second electrodes such that ina first time period, the first and second electrodes have the first andsecond phase angles respectively and in a second time period, the firstand second electrodes have the second and first phase anglesrespectively.
 26. The method of claim 25 further comprising the step ofcontrolling the duty cycle of the power with the duty cycle having an onperiod and an off period.
 27. The method of claim 26 further comprisingthe step of changing the phase angles of the power provided to theelectrodes during the off periods of the respective duty cycles.
 28. Themethod of claim 26 further comprising the steps of:sensing thetemperature at the electrodes and providing a temperature signalrepresentative of the sensed temperature; and controlling the duty cycleof the power in response to the temperature signal.
 29. The method ofclaim 26 further comprising the steps of:sensing at least onecharacteristic of the power applied to at least one electrode andproviding a power measurement signal; determining an impedancemeasurement based on the power; and controlling the duty cycle of thepower in response to the power measurement signal.
 30. The method ofclaim 29 further comprising the steps of:sensing the temperature at anelectrode and providing a temperature signal representative of thesensed temperature; and controlling the duty cycle of the power inresponse to the temperature signal and to the power measurement signal.31. The method of claim 25 further comprising the step of controllingthe phase angles of the power provided to the electrodes such that thepower differs in phase by an amount greater than zero degrees but lessthan 180 degrees.
 32. The method of claim 25 further comprising the stepof controlling the phase angles of the power provided to the electrodessuch that the power between two electrodes differs in phase by an amountapproximately equal to 132 degrees.
 33. The method of claim 25 furthercomprising the step of providing separate power to each of the pluralityof electrodes with the power provided to each electrode beingindividually controlled as to phase angle.